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Spinal Morphine for Postoperative Analgesia in Urology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675646
Recruitment Status : Completed
First Posted : September 18, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Jiri Malek, Charles University, Czech Republic

Brief Summary:
The study was performed in urology patients elicited for open prostatectomy or open nephrectomy. Comparison of analgesic effect between group (M) with spinal morphine before general anaesthesia and group without this intervention was measured.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Morphine Phase 4

Detailed Description:

Patients elicited for open prostatectomy or open nephrectomy were randomly divided in 2 groups. Group M were administered preservative-free morphine 250 mcg in 2.5 ml NS intrathecal using 25 G needle in L1/2 - L5/S1 interspaces. Control group (C) were given no intervention. Placebo intrathecal injection in C was not used because of ethical reason. Standard general anaesthesia was used in both groups. After surgery all patients were transferred to urology ICU and were given standard analgesic regimen according to level of pain measured by numeric rating scale (NRS) 0 - 10: NRS > 3 metamizol 1 g IV every 6 h., max. 4 g/24 h., NRS > 3 paracetamol 1g IV every 6 h., max. 4 g/24 h., NRS > 3 lasting 30 min. after administration of previous ones diclofenac 75 mg IM á 12 h., max. 150 mg/24 h., NRS > 4 morphine 10 mg SC á 6 h. Personnel of ICU was blinded to the analgesic method used.

Noticed parameters: pain intensity (NRS), time to NRS ≥ 4, time to the first morphine request, side effects (respiratory rate <8, SpO2<90 %, nausea, vomiting, naloxone administration for SpO2<88 %, itching).

Standard statistical analysis was used, p value < 0.05 was considered significant.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Patient elicited for open prostatectomy or open nephrectomy were given intrathecal morphine in normal saline before induction to general anaesthesia (GA) or GA only. After surgery, time to the first opioid request, total opioid consumption during first 24 hours and 48 hours after surgery and opioid side effects were noticed.
Masking: Single (Outcomes Assessor)
Masking Description: Only ICU personnel was blinded to the method used
Primary Purpose: Treatment
Official Title: Comparison of Spinal Morphine With Systemic Analgesia After Urologic Surgery
Actual Study Start Date : March 5, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : July 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Morphine group M
Experimental group M were administered preservative-free morphine 250 mcg in 2.5 ml NS intrathecal using 25 G needle in L1/2 - L5/S1 interspaces.
Drug: Morphine
Intrathecal injection of 250 mcg preservative-free morphine before surgery
Other Name: No other names

No Intervention: Control group C
No intervention



Primary Outcome Measures :
  1. Duration of analgesia [ Time Frame: 48 hours ]
    Time to the first morphine request during the first two days of ICU stay after surgery (in hours) and total morphine consumption during the first two days of ICU stay (in mg)


Secondary Outcome Measures :
  1. Morphine side effects [ Time Frame: 48 hours ]
    respiratory rate <8, SpO2<90 %, nausea, vomiting, naloxone administration for SpO2<88 %, itching



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • elicited open prostatectomy or open nephrectomy

Exclusion Criteria

  • drug or alcohol dependence
  • psychiatric drug use
  • ASA classification IV or V
  • general contraindication to neuroaxial injection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675646


Locations
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Czechia
University Hospital Kralovske Vinohrady
Praha, Czechia, 100 00
Sponsors and Collaborators
Charles University, Czech Republic
Investigators
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Principal Investigator: Jiri Malek, M.D. 3rd Medical Faculty, Charles University
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Responsible Party: Jiri Malek, Assoc. Prof., M.D., Ph.D., Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT03675646    
Other Study ID Numbers: malekj3
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiri Malek, Charles University, Czech Republic:
morphine spinal
prostatectomy
nephrectomy
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents